MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PATELLA 35MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Rupture (2208)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - persona natural cemented stemmed tibial component size e left catalog #: 42532007101 lot #: 63189523, persona ultracongruent fixed bearing articular surface 11mm left catalog #: 42512200511 lot #: 62335084, persona trabecular metal curciate retaining narrow porous femoral component catalog #: 42502206201 lot #: 63199066.It was indicated by the complainant that the device would not be returned to zimmer biomet for investigation, as the device remains implanted.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies relevant to the reported event were identified.Review of the primary operative noted that the patient was suffering from severe left knee osteoarthritis.No intraoperative complications were noted and the knee was noted to have excellent stability throughout range of motion while maintaining full motion.Review of operative report from the patient's retinacular repair noted that there was no evidence of infection and that the components were intact.There was a small retinacular rent that was repaired with vicryl and the knee tracked nicely through range of motion.Per package insert for the persona knee system, pain and swelling are some of the known adverse effects of total knee arthroplasty.However, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report was previously submitted erroneously on apr 6, 2018 and may 22, 2018 under manufacturing report number 0001822565-2018-02057.

Event Description

It is reported that the patient underwent a left knee retinaculum repair three months post-operatively due to pain, swelling, redness, a hematoma and retinacular rupture.During the procedure, all components were found to be intact.

• Brand Name: PERSONA ALL POLY PATELLA 35MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7751452
• MDR Text Key: 116053108
• Report Number: 0002648920-2018-00554
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42540000035
• Device Lot Number: 63432243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 84